| CTRI Number |
CTRI/2024/08/071870 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early movement in patients after surgery makes them to improve their body function |
|
Scientific Title of Study
|
Effectiveness of early mobilization on functional performance in post surgical patients - A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanka guru venkata sai sharmila priyanka |
| Designation |
post graduate student |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5TH Floor
SRM college of physiotherapy
SRM institute of science and technology
SRM nagar
potheri
kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09989519070 |
| Fax |
|
| Email |
gv8731@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
D Anandhi |
| Designation |
Proffesor |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT14 5TH Floor
SRM college of physiotherapy
SRM institute of science and technology
SRM nagar
potheri
kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
D Anandhi |
| Designation |
Proffesor |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT14 5TH Floor
SRM college of physiotherapy
SRM institute of science and technology
SRM nagar
potheri
kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM college of physiotherapy
SRM institute of science and technology
SRM nagar
Potheri
Kattankulathur
Tamil Nadu
603203
India
|
|
|
Primary Sponsor
|
| Name |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5TH Floor
SRM college of physiotherapy
SRM institute of science and technology
SRM nagar
potheri
kattankulathur
Kancheepuram
Tamil Nadu
603203
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vanka guru venkata sai sharmila priyanka |
SRM Medical College Hospital And Research Centre |
Ground floor GynecICU
First floor Surgical ICU Post anesthesia care unit
SRM Medical College Hospital And Research Centre
SRM nagar
Potheri
Kattankulathur
Kancheepuram
Tamil Nadu
603203
India
Kancheepuram
TAMIL NADU |
9989519070
gv8731@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, (4) ICD-10 Condition: K450||Other specified abdominal hernia with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Physiotherapy treatment given for patients after surgery |
physiotherapy treatment is given 2 times a day and for duration of 40 minutes per session
Total duration of treatment 3 to 7 days |
| Comparator Agent |
Physiotherapy treatment not given for patients after surgery |
as physiotherapy treatment is not given in comparative agent
Total duration of treatment is 3 to 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients undergone gastrointestinal surgeries, all abdominal surgeries, surgical hysterectomy and orthopedic surgeries (upper limb surgeries and ribs fractures)
2 Patients immediately weaning off from mechanical ventilation.
3 Conscious and alert subject
4 Group A patients referred by physician for physiotherapy/early mobilization
5 Group B patients not referred by physician for physiotherapy/early mobilization
|
|
| ExclusionCriteria |
| Details |
1 Children or minors, positive pregnancy test
2 Patients with cardio thoracic surgeries, transplantation surgeries (kidney, liver, bowel) cataract surgeries, malignancy surgeries, neuro surgeries, orthopedic surgeries (lower limb surgeries), lower segment caesarian section (LSCS) and malignancies surgeries
3 Patients who are unconsciousness and un- cooperative
4 Patients included in any other trails
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PERME ICU MOBILITY SCORE |
after surgery
baseline
at first day
at second or third day
at one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FUNCTIONAL INDEPENDENCE MEASURE FIM |
after surgery
baseline
at first day
at second or third day
at one week |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND An admission to the Intensive care unit for many patients despite advances in diagnostics and therapeutics and general reductions in mortality remains an event where many are left with a significant post intensive care morbidity The surgical intensive care unit (SICU) or a combined medical surgical ICU is a specialized patient care area designed for critically ill surgical patients It provides care for patients recovering from gastro intestinal surgeries vascular surgeries RTA orthopedic surgeries gynecological surgeries The national estimation after standardization was 3646 surgeries per year per 100000 Indian population 26percentage would be general surgical procedures 20 percent would be obstetrics and gynecological surgeries and 13 percent would be Ophthalmological surgeries After surgery patients may experience some of the most common complications like shock hemorrhage wound infection deep vein thrombosis lung complications urinary retention The early mobilization of the patient in the ICU has received considerable attention in clinical and scientific literature over past several years Long term ICU care is associated with complications Prolonged period of immobility has often been associated with physical deconditioning muscle weakness loss of function muscle wasting and decreased quality of life Outcome measures in surgical ICU are tools used to assess the physical function and recovery of patients who have under gone surgery Types of outcome measures used in ICU are APACHE SAPS MODS SOFA GCS But these tools are not sensitive to measure ICU mobility status METHODS A single arm study two arm parallel group type of the study is quasi experimental study and the study design is comparative study with a sample size of 44 for duration of 6 months and the study setting is SICU PACU Gynac ICU of SRM medical college hospital and research center
DISCUSSION This study will let us know the importance of a early mobilization in a patient after surgery with undergoing physiotherapy treatment and how the complications are omitted through physiotherapy after surgery and also the functional performance of daily living is to be improved after surgery and this can be improved with early mobilization with physiotherapy treatment after surgery
|